(425 days)
The FaceMaster Facial Toning System ("FaceMaster System") is intended to stimulate the face. The device is indicated for cosmetic use.
The FaceMaster System is a transcutaneous electrical stimulator that incorporates a control module and two electrodes on separate, handheld probes to deliver electrical stimulation to the face muscles. The device is prepared for use by laying it flat on a table, opening the control module cover and removing the probes from their cradles inside the control module. Conductive solution is dispensed into a basin within the control module and, after placing the foam pads over the distal end of each probe the pads are soaked in the solution until they are moist. The user then pushes the power (ON/OFF) button to turn the device on and follows the instructions for use and the LCD and audible prompts from the control module to complete the three cosmetic stimulation modes, i.e., the eye cycle, the facial cycle, and the feathering cycle.
The provided text describes the 510(k) summary for the FaceMaster® Facial Toning System (K040871). Here's an analysis to extract the requested information:
Acceptance Criteria and Study Details for FaceMaster® Facial Toning System (K040871)
1. Table of Acceptance Criteria and Reported Device Performance
The submission for K040871 is primarily a substantial equivalence claim based on predicate devices and a clinical study that included "trained observers and self-assessments." It explicitly states that the device "complies with FDA's performance standard for electrode lead wires and patient cables set forth in 21 C.F.R. § 898.12."
However, no specific quantitative acceptance criteria or a reported performance matrix (e.g., sensitivity, specificity, accuracy, or a specific metric for "toning") are provided in the document. The study's purpose was to "demonstrate the substantial equivalence... for OTC cosmetic use," implying the performance was considered "substantially equivalent" to the predicate, rather than meeting predefined quantitative metrics.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No specific quantitative acceptance criteria are provided in the document for the cosmetic effects of facial toning. | The clinical study, including trained observers and self-assessments, supported the device's substantial equivalence to predicate devices for OTC cosmetic use. |
| Compliance with FDA performance standard for electrode lead wires and patient cables (21 C.F.R. § 898.12). | The device complies with 21 C.F.R. § 898.12. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "A clinical study of the FaceMaster System," but does not specify the sample size for this study or whether it had a distinct "test set." It also does not mention the country of origin of the data nor if it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The study "included testing both with trained observers and self-assessments."
- Number of Experts: Not specified.
- Qualifications of Experts: The term "trained observers" is used, but no specific qualifications (e.g., dermatologists, cosmetologists, level of experience) are provided.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method used for the "trained observers" or self-assessments.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This section is not applicable. The FaceMaster System is a direct-to-consumer electrical stimulation device, not an AI-assisted diagnostic or imaging interpretation tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This section is not applicable. The FaceMaster System is a physical device used directly by a human, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the clinical study appears to be a combination of:
- Trained Observer Assessments: Subjective evaluations by individuals trained for the purpose of the study.
- Self-Assessments: Subjective evaluations provided by the users themselves.
8. The Sample Size for the Training Set
The document does not specify a separate training set or its sample size. The clinical study mentioned appears to be the primary study for evaluation, not a split into training and test sets in the machine learning sense.
9. How the Ground Truth for the Training Set Was Established
Since a dedicated "training set" is not mentioned, the method for establishing its ground truth is not applicable.
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).